After Keros Therapeutics Inc.’s voluntary halt of dosing in two arms of its phase II study in pulmonary arterial hypertension, the company’s stock crumpled after a year of muscular performance and its recent and massive deal with Takeda Pharmaceutical Co. Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cipla, Mannkind, Pilatus, Sanofi, Santhera, Theratechnologies.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aliada, Asahi Kasei, Bayer, Biopath Holdings, Cellactar, Chiome, Hepion, Hong Kong King-Friend Industrial, Immunogenesis, Meitheal, Moberg, Monte Rosa, Novartis, Negev Labs, Pharma Two B, Phathom, Polypid, VBI Vaccines.
Nearly three years after being terminated as president and CEO of Cytodyn Inc., Nader Pourhassan was convicted June 9 by a U.S. federal jury for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab. The jury also convicted Kazem Kazempour, the CEO of Amarex Clinical Research LLC, a contract research organization hired by Cytodyn, for his part in the scheme.
Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.
CNS specialist Noema Pharma AG has added a further $44 million to its series B, bringing the total for the round to $147 million. The new financing bolsters the balance sheet as the Basel, Switzerland-based company progresses four phase II trials, with key data readouts expected in 2025.
Sound Pharmaceuticals Inc.’s lead candidate, the anti-inflammatory SPI-1005 (ebselen), has produced positive pivotal phase III study data in treating Meniere’s disease, an inner-ear disorder that can lead to vertigo and deafness.